Merits and demerits of DES, DEB or covered stent in lower extremity arterial occlusive disease 성균관의과대학삼성서울병원순환기내과최승혁

Merits and demerits of DES, DEB or covered stent in lower extremity arterial occlusive disease 성균관의과대학삼성서울병원순환기내과최승혁

Contents DES in SFA DES in BTK DEB in SFA DEB in BTK Current status of covered stent DES and DEB in ISR

SFA treatment before Era of DES and DEB Schillinger M, J Endovasc Ther. 2009;16:I147-I152

DES DES vs. BMS in the SFA SIROCCO II STRIDES DES Zilver PTX DES vs. BMS in BTK arteries YUKON-BTK ACHILLES DESTINY

SIROCCO II trial DES in SFA Multicenter randomized study 93 patients SES BMS Patients 47 46 Age 66.3 65.9 Lesion Length (mm) 85±44 81±52 Total occlusion 69% 57% Restenotic lesion 11% 4% Moderate-severe calcification 57% 35% 92.8% 83.8% Duda S, J Endovasc Ther 2006;13:701-10

Zilver PTX trial DES in SFA 82.7% 65.3% 73.4% 32.7% 89.9% 73.0% Dake MD, Circulation 2011;4:495-504

ACHILLES trial DES in BTK CYPER (n=99) PTA (n=101) P-value Age, years 72.4±9.4 74.3±8.2 0.117 Diabetes,% 64.6 64.4 1.000 Lesion length, mm Total occlusion,% 26.9±20.9 26.8±21.3 0.990 81.3 75.4 0.334 Scheinert D, et al LINC 2011

DESTINY trial DES in BTK EES 85.2% BMS 54.4% Bosiers M, J Vasc Surg 2012;55:390-9

DES in lower extremity artery Paclitaxel eluting stent has demonstrated to be superior to BMS in SFA within the 2 year. Sirolimus and Everolimus eluting stent have demonstrated to be superior to BMS in BTK lesions within the first year. This may be important specifically for patients with CLI who need early wound healing

DEB in SFA 4 RCTs Thunder FemPac Levant I Pacifier Atherctomy + DEB vs. DEB only DEFINITIVE AR : randomized trial

The Value of DEB for SFA lesions Late Lumen Loss Thunder Fem Pac Levant I Pacifier Mean lesion length 7.5cm 5.7cm 8.1cm 7.0cm 4 RCTs showed superiority of the DEB vs. non-coted balloons in SFA-lesions Tepe G, NEJM 2008;358:689 Werk M, Circulation 2008;118:1358-65

Atherectomy + DEB Recoil/ Residual Stenosis after Balloon DEFINITIVE AR Randomized pilot study Plaque excision +DEB vs. DEB only 100 patients with SFA lesion On-going trial After stenting Solution: stenting or atherectomy before PTA Should it be compared to Zilver PTX?

DEB in BTK Registry data : DEB vs. POBA

Single arm registry data 104 patients, 109 limbs 3 mo POB BTK DEB BTK Lesion-length 183mm 173mm Restenosis >50% @ 3 Mo 69% 27% 61% restenosis reduction Limb-salvage @ 12 Mo 100% 96% Schmidt A, JACC 2011;58:1105-9 Schmidt A, CCI 2010;76:1047-54 TLR rate @ 12 Mo 50% 17% 65% TLR-rate reduction

DEB in BTK Registry data : DEB vs. POBA Randomized trials DEB BTK IN.PACT DEEP In. PACT Amphirion PTX-eluting balloon (Medtronic) vs. uncoated Amphirion Deep balloon PICCOLO Paccocath vs. standard balloon

DEB in lower extremity artery DEB has improved the results of POBA in primary lesions DEB might be less effective because the drug might not reach the target Thrombus-containing lesions Heavy calcified lesions

Covered Stent eptfe/nitinol Stent graft Gore Viabahn

Stent graft vs. PTA Multicenter randomized study 1998-1999 Stent graft 65% p=0.0003 40% PTA Saxon RR, J Vasc Interv Radiol 2008;19:823-32

Stent graft vs. Fem-pop bypass Prospective randomized study 2004-2005 4 year follow up data 72.0% Stent graft 59.0% 58.0% Bypass McQuade K, J Vasc Surg 2010;52:548-91

Covered stent (GORE VIABAHN) PROPATEN Bioactive Surface April 2009 Contoured proximal edge April 2009 25cm Length July 2010 6/7 French Profile/0.018 guidewire January 2011 VIPER VIASTAR (RCT) VIABHAN Long lesion VIBRANT 3 year data (RCT)

VIASTAR trial Multicenter randomized study 138 patients VIABAHN Patients 71 67 Age 68 69 BMS Lesion Length (cm) 24.1 20.1 TASC classification TASC B 28.2% 31.3% TASC C 36.7% 40.3% TASC D 35.1% 28.4% Diameter(mm) 5.4 5.4 Preliminary results 12 month F/U VIABAHN BMS Patients 38/71 33/67 >50% restenosis 3 17 Occlusion 9 5 TLR 8 13 Bypass Surgery 2 0 12 month restenosis/occlusions VIABAHN 12/38 =31.6% BMS : 22/33 =66.6% Lammer J, VEITH symposium. Nov. 2011

VIBRANT 3 year results Patients 72 78 VIABAHN BMS P value Total occlusion 61.1% 56.6% 0.62 Lesion Length (cm) 19±8 18±7 0.87 Moderate-severe calcification 62.5% 42.1% 0.01 Technical success 97% 96% 1.0 Distal runoff 0.10 3 vessel 34.7% 44.7% 2 vessel 50.0% 32.9% Primary Patency (PSVR >2.0) 6mo 1 yr 2 yr 3 yr VIABAHN 68 47 35 24 BMS 70 55 39 26 Mewissen MW, VEITH symposium. Nov. 2011

Merits and demerits of stent graft Provide mechanical barrier to intimal hyperplasia Intimal hyperplasia at the edges of stent graft graft thrombosis d/t delayed endothelization or edge restenosis Occlude flow into branch vessels and collaterals. Smaller diameter or oversized stent graft should be avoided Long term data for TASC C, D lesion is disappointing

Current treatment option for ISR Cutting balloon : 73% restenosis rate at 6 months SilverHawk : 49% restenosis at 18 months Cryoballoon : 100% failure after 12 months Dick P, Radiology 2008;248:297-302 Zeller T, JACC 2006;48:1573-8

DES and DEB in ISR Zilver PTX ISR PACUBA trial

Zilver PTX ISR registry data Zilver PTX : primary patency Single arm study All patients Single arm study Lesions with ISR Lesions 900 142 Lesion length(mm) 100±82 127±90 Diameter stenosis 85±16% 87±12% Lesions >7cm 48% 62% Lesion >15cm 22% 33% Zilver PTX : Freedom from TLR Total occlusion 38% 31% ISR 14% 100% Bosiers M, VEITH symposium. Nov. 2011

PACUBA trial Paclitaxel Coated DEB for ISR Symptomatic ISR in SFA 60 patients will be enrolled Preliminary results POBA DEB Patients 15 21 Age(years) 70 68 Lesion length (cm) 8.1 8.5 Total occlusion 5 5 6 months PP rate 37% 78% Lammer J, VEITH symposium. Nov. 2011

DES and DEB in ISR Zilver PTX ISR PACUBA trial FAIR DEB vs. PTA alone RELINE Viabahn vs. PTA alone PHOTOPAC trial Booster laser atherectomy + DEB vs. DEB only

Treatment option for ISR No consensus exists on how to treat ISR in the SFA DES : first promising results from ZILVER PTX registry DEB & Viabahn : results coming soon

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